SULFACETAMIDE SODIUM solution/ drops

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)

Διαθέσιμο από:

STAT RX USA LLC

INN (Διεθνής Όνομα):

SULFACETAMIDE SODIUM

Σύνθεση:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Οδός χορήγησης:

OPHTHALMIC

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs. Sulfacetamide Sodium Ophthalmic Solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

Περίληψη προϊόντος:

Sulfacetamide Sodium Ophthalmic Solution USP, 10% is supplied sterile in plastic bottles in the following sizes: 15 mL: NDC 61314-701-01 Note: Store between 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded. Rx Only Dist. by: FALCON Pharmaceuticals, Ltd Fort Worth, Texas  76134 Mfd. by: ALCON LABORATORIES, INC. Fort Worth, Texas  76134 Printed in USA

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SULFACETAMIDE SODIUM - SULFACETAMIDE SODIUM SOLUTION/ DROPS
STAT RX USA LLC
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DESCRIPTION
Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical
antibacterial agents for ophthalmic
use. The active ingredient is represented by the following structural
formula:
CHEMICAL NAME:
N-Sulfanilylacetamide monosodium salt monohydrate.
C H N Na0 S·H O
MW = 254.24
CONTAINS :
ACTIVE: sulfacetamide sodium 10% (100 mg/mL).
PRESERVATIVE: methylparaben and propylparaben
INACTIVES: sodium thiosulfate, methylcellulose, and monobasic sodium
phosphate
CLINICAL PHARMACOLOGY
MICROBIOLOGY
The sulfonamides are bacteriostatic agents and the spectrum of
activity is similar for all. Sulfonamides
inhibit bacterial synthesis of dihydrofolic acid by preventing the
condensation of the pteridine with
aminobenzoic acid through competitive inhibition of the enzyme
dihydropteroate synthetase. Resistant
strains have altered dihydropteroate synthetase with reduced affinity
for sulfonamides or produce
increased quantities of aminobenzoic acid.
Topically applied sulfonamides are considered active against
susceptible strains of the following
common bacterial eye pathogens: _Escherichia coli, Staphylococcus
aureus, Streptococcus pneumoniae,_
_Streptococcus_ (viridans group), _Haemophilus influenzae, Klebsiella
_species, and _Enterobacter _species.
Topically applied sulfonamides do not provide adequate coverage
against _Neisseria_ species, _Serratia_
_marcescens_ and _Pseudomonas aeruginosa._ A significant percentage of
staphylococcal isolates are
completely resistant to sulfa drugs.
INDICATIONS AND USAGE
Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated for the
treatment of conjunctivitis and
other superficial ocular infections due to susceptible microorganisms,
and as an adjunctive in systemic
sulfonamide therapy of trachoma:
_Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae,
Streptococcus_ (viridans group),
_Haemophilus influenzae, Klebsiella_ species, and _Enterobacter_
species.
8
9
2
3
2
Topically app